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RSS FeedPosted by Michael Wonder on 26 Aug 2022
Patient registries: EMA officials highlight opportunities in orphan drug development
25 August 2022 - Officials from the EMA tout the benefits of patient registries to support regulatory decision making for ...
Posted by Michael Wonder on 30 Nov 2018
Data from patient registries to replace clinical trials in previously untreated haemophilia patients
30 November 2018 - EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications ...
Posted by Michael Wonder on 15 Nov 2018
EMA seeks feedback on using registries for regulatory purposes
15 November 2018 - The EMA is seeking feedback on the use of patient disease registries for regulatory purposes. ...
Posted by Michael Wonder on 22 May 2018
EMA report makes recommendations for CAR-T patient registries
22 May 2018 - A new report from the EMA lays out recommendations for improving the use of patient registries ...
Posted by Michael Wonder on 13 Oct 2015
Collecting high-quality information on medicines through patient registries
12 October 2015 - The European Medicines Agency (EMA) has launched an initiative on patient registries aimed at making better use ...